FDA Device recall Z-0879-2023
Detect Covid-19 Test Product/Model Number: 21205
- FDA Device
- Class II
- ongoing
- Published 2023-01-11
On 2023-01-11 the FDA classified a Class II recall of Detect Covid-19 Test Product/Model Number: 21205 by Detect Headquarters, citing there is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of suppor….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0879-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-08 |
| Published | 2023-01-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Detect Headquarters |
| Distribution | US |
Product
Detect Covid-19 Test Product/Model Number: 21205
Reason
There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community.
Identifiers
| code_info | HY263, HY264, and HB264 Expiration 01JAN2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0879-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.